ShameMISTNCT05106959
Piloting a Motivational Interviewing Shame-Resilience Training
A study of Shame, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shame
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study participants will be Milagro patients
- Engaged in medication assisted treatment
- At least 18 years of age
- Can read and speak English
- Are willing to be contacted for follow-up \
- Are not incarcerated
- Are within the first or second trimester of pregnancy
Who cannot join
- The study will not enroll non-English speaking Milagro patients
- Patients with obvious cognitive impairments
- Patients with the inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
South-East Heights Clinic
Albuquerque, New Mexico, 87108
About this study
The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Continued research is needed to assess shame-resilience as a potential intervention for shame which little is known to combat prevalent negative health outcomes associated with shame.
Read the detailed description
Shame is an emotion that can have significant negative impacts on health outcomes, including engagement in care. Feelings of shame are commonly experienced with stigmatized behaviors, such as substance misuse, and may be particularly strong among pregnant women who misuse substances. Rates of opioid misuse during pregnancy are dramatically rising, particularly in New Mexico, leading to negative health outcomes for mothers and fetuses. Shame has been found to decrease these patients' willingness to attend and engage in care. Although a theoretical model is available to guide interventions to reduce shame, it has not been tested empirically. In the current study, investigators seek to evaluate the preliminary effectiveness and feasibility of a brief Shame Resilience Intervention among women seeking care in UNM's Milagro program, a prenatal medical clinic for opioid using pregnant women. This research has the potential to significantly improve public health by generating a tool to reduce barriers to care.
- Conditions
- Shame
- Being tested
- Motivational Interviewing Informed Shame Resilience Training
- Keywords
- shame resilience, motivational interviewing, shame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing Informed Shame Resilience TrainingBehavioural
Shame resilience involves four elements. Understating shame, normalizing shame thoughts, reaching out, and speaking shame. Motivational interviewing will be used to elicit and guide participants through these four elements.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Training | Experimental | In this arm participants will complete a variety of baseline assessments then participate in 15-20 minute conversation based on motivational interviewing principles in which they are trained in shame resilience. Follow-ups will be conducted a month later. Assessments will be repeated and then participants will engage in a qualitative interview regarding the training. Receives: Behavioral: Motivational Interviewing Informed Shame Resilience Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Communicate
This measure looks at participants willingness to communicate about their health on a 5 point Likert Scale; 1-5 with higher scores indicating a greater willingness to communicate. Participants respond to a series of questions on a questionnaire.
Measured: 1-month
Adult Trauma Symptom Checklist
This measure looks at current symptoms of past trauma experiences on a 4 point Likert scale; 0-3 with higher scores indicating a greater presence of adult trauma symptoms. Participants respond to a questionnaire.
Measured: 1-month
Shame Compass
This measure looks at the intensity and frequency of shame experiences on a 4 point Likert Scale; 0-3 with higher scores indicating a greater intensity and frequency of shame experiences. Participants respond to a questionnaire.
Measured: 1 month
WHO Big 5 Subjective Well-Being
This measure looks at participants well-being over the past two weeks on a 6 point Likert Scale; 0-5. Scores range from a minimum of 0 to a maximum of 25, with higher scores indicating a better subjective well-being. Participants respond to a questionnaire.
Measured: 1-month
Shame Resilience Amongst Mental Health Trainees
This measure looks at how much a participant is practicing shame resilience on a 4 point Likert Scale; 0-3 with higher scores indicating better shame resilience. Participants respond to a questionnaire.
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start26 Jun 2020
- Primary completion16 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ShameStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal single group pilot study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hettema, University of New Mexico
- Investigators
- Jennifer Hettema, PhD, Principal investigator, University of New Mexico Department of Family and Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106959
- Sponsor's protocol ID
- 20-059
- Acronym
- MIST
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We currently don't have an IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Motivational Interviewing Shame-Resilience Training
- ClinicalTrials.gov ID
- NCT05106959
- Acronym / sponsor ID
- MIST / 20-059
- Conditions
- Shame
- Keywords
- shame resilience, motivational interviewing, shame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Continued research is needed to assess shame-resilience as a potential intervention for shame which little is known to combat prevalent negative health outcomes associated with shame.
Detailed description
Shame is an emotion that can have significant negative impacts on health outcomes, including engagement in care. Feelings of shame are commonly experienced with stigmatized behaviors, such as substance misuse, and may be particularly strong among pregnant women who misuse substances. Rates of opioid misuse during pregnancy are dramatically rising, particularly in New Mexico, leading to negative health outcomes for mothers and fetuses. Shame has been found to decrease these patients' willingness to attend and engage in care. Although a theoretical model is available to guide interventions to reduce shame, it has not been tested empirically. In the current study, investigators seek to evaluate the preliminary effectiveness and feasibility of a brief Shame Resilience Intervention among women seeking care in UNM's Milagro program, a prenatal medical clinic for opioid using pregnant women. This research has the potential to significantly improve public health by generating a tool to reduce barriers to care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal single group pilot study.
| Arm | Type | Receives |
|---|---|---|
| Pilot Training | Experimental | Behavioral: Motivational Interviewing Informed Shame Resilience TrainingIn this arm participants will complete a variety of baseline assessments then participate in 15-20 minute conversation based on motivational interviewing principles in which they are trained in shame resilience. Follow-ups will be conducted a month later. Assessments will be repeated and then participants will engage in a qualitative interview regarding the training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Study participants will be Milagro patients
- Engaged in medication assisted treatment
- At least 18 years of age
- Can read and speak English
- Are willing to be contacted for follow-up \
Key exclusion criteria (3 listed)
- The study will not enroll non-English speaking Milagro patients
- Patients with obvious cognitive impairments
- Patients with the inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing Informed Shame Resilience TrainingShame resilience involves four elements. Understating shame, normalizing shame thoughts, reaching out, and speaking shame. Motivational interviewing will be used to elicit and guide participants through these four elements. | Behavioural | Pilot Training |
Primary outcome
Willingness to Communicate
Time frame: 1-month
This measure looks at participants willingness to communicate about their health on a 5 point Likert Scale; 1-5 with higher scores indicating a greater willingness to communicate. Participants respond to a series of questions on a questionnaire.
Adult Trauma Symptom Checklist
Time frame: 1-month
This measure looks at current symptoms of past trauma experiences on a 4 point Likert scale; 0-3 with higher scores indicating a greater presence of adult trauma symptoms. Participants respond to a questionnaire.
Shame Compass
Time frame: 1 month
This measure looks at the intensity and frequency of shame experiences on a 4 point Likert Scale; 0-3 with higher scores indicating a greater intensity and frequency of shame experiences. Participants respond to a questionnaire.
WHO Big 5 Subjective Well-Being
Time frame: 1-month
This measure looks at participants well-being over the past two weeks on a 6 point Likert Scale; 0-5. Scores range from a minimum of 0 to a maximum of 25, with higher scores indicating a better subjective well-being. Participants respond to a questionnaire.
Shame Resilience Amongst Mental Health Trainees
Time frame: 1-month
This measure looks at how much a participant is practicing shame resilience on a 4 point Likert Scale; 0-3 with higher scores indicating better shame resilience. Participants respond to a questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We currently don't have an IPD sharing plan.
Related trials for Shame
Not yet recruitingObservational study
Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol
Intimate Partner Violence, Intimate Partner Violence Against Women
RecruitingObservational study
Validation of the Swedish Translation of a Brief Shame Measure, the External and Internal Shame Scale
Shame
RecruitingObservational study
How a Resilience-Focused Intervention is Perceived by Women Subjected to Domestic Violence
Shame, Intimate Partner Violence
Recruiting
Shame-Focused Cognitive Behavioral Therapy For Reducing Suicide Risk In Adolescent Psychiatric Inpatients (SF-CBT)
Adolescent Suicide, Suicidal Ideation
Recruiting
Healthy Recovery After Trauma Study
Stress Disorders, Post-Traumatic, Shame
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hettema, PhD principal investigator
University of New Mexico Department of Family and Community Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Shame, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to Communicate (time frame: 1-month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.